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Sponsored by: |
Tissue Regeneration Technologies |
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Information provided by: | Tissue Regeneration Technologies |
ClinicalTrials.gov Identifier: | NCT00366132 |
The purpose of this clinical study is to compare the safety and effectiveness of shockwave treatment combined with standard-of-care treatment, to standard-of-care treatment alone to induce healing of a chronic plantar foot ulcer in subjects with diabetes mellitus. For the purpose of this study, the definition of plantar foot ulcer is a wound or open sore that involves the plantar(bottom) aspect of the foot, and the definition of chronic is a duration of 6 weeks or greater with a lack of response to treatment.
Condition | Intervention | Phase |
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Chronic Diabetic Foot Ulcers |
Device: Extracorporeal Shockwaves |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | DermaGold Indicated for Use of Shockwave Treat of Diabetic Foot Ulcers in Patients With Diabetes Mellitus |
Estimated Enrollment: | 200 |
Study Start Date: | March 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, District of Columbia | |
Georgetown University Hospital | Recruiting |
Washington, D.C., District of Columbia, United States, 20007 | |
Contact: Rene Laughlin, RN 202-444-7288 | |
Principal Investigator: Christopher Attinger, MD | |
United States, New York | |
Calvary Hospital | Recruiting |
Bronx, New York, United States, 10461 | |
Contact: Linda Waltrous 718-518-2149 | |
Principal Investigator: Oscar Alvarez, Ph.D.,WCA | |
United States, Ohio | |
Akron General | Recruiting |
Akron, Ohio, United States, 44307 | |
Contact: Dawn Sues, RN 330-344-1122 | |
Principal Investigator: David Kay, MD | |
United States, Texas | |
University of Texas Medical Branch | Recruiting |
Galveston, Texas, United States, 77555 | |
Contact: Matthew Wagener, BS 409-747-5749 | |
Principal Investigator: Saul Trevino, MD | |
Podiatry Group of South Texas | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Rebecca Reyes 830-981-5150 | |
Principal Investigator: Richard L Childers, DPM |
Study ID Numbers: | G050198 |
Study First Received: | August 17, 2006 |
Last Updated: | August 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00366132 |
Health Authority: | United States: Food and Drug Administration |
Diabetic Foot Ulcers TRT DermaGold |
Shockwave ESWT Diabetes Mellitus |
Foot Ulcer Metabolic Diseases Diabetic Neuropathies Skin Diseases Ulcer Diabetes Mellitus Vascular Diseases Endocrine System Diseases Foot Diseases |
Diabetic Angiopathies Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Skin Ulcer Diabetes Complications Diabetic Foot Leg Ulcer |
Pathologic Processes Cardiovascular Diseases |